The following data is part of a premarket notification filed by Bioventus Llc with the FDA for Mcs Bone Graft.
| Device ID | K162860 |
| 510k Number | K162860 |
| Device Name: | MCS Bone Graft |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOVENTUS LLC 4721 EMPEROR BLVD SUITE 100 Durham, NC 27703 |
| Contact | John Brunelle |
| Correspondent | Patsy J. Trisler Trisler Consulting 5600 Wisconsin Ave Chevy Chase, MD 20815 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-12 |
| Decision Date | 2017-02-13 |
| Summary: | summary |